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FDA 510(k)

FIXATION PIN OR ROD

K-Number: K970036 · 1997-03-25

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1997-03-25
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXATION PIN OR ROD is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1997-03-25 under 510(k) number K970036. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXATION PIN OR ROD?

FIXATION PIN OR ROD is a medical device that received FDA 510(k) clearance on 1997-03-25. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K970036.

When did FIXATION PIN OR ROD receive FDA 510(k) clearance?

FIXATION PIN OR ROD received FDA 510(k) clearance on 1997-03-25, under 510(k) number K970036.

Who is the listed applicant for FIXATION PIN OR ROD?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIXATION PIN OR ROD?

The FDA product code for FIXATION PIN OR ROD is HTY.

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Other records listing United States Surgical, A Division of Tyco Healthc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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